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| ID | Type | Description | Link |
|---|---|---|---|
| 2026-525642-30-00 | EU Trial (CTIS) Number |
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This is a study to evaluate the effect on LDL-C and the safety and tolerability of FDC laroprovstat/rosuvastatin in LLT-naïve patients. Laroprovstat is a small molecule that reduces the amount of LDL-C in the blood. Laroprovstat and FDC laroprovstat/rosuvastatin are being developed for the treatment of hypercholesterolaemia.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Laroprovstat | Active Comparator | The patient will receive a daily dose of Laroprovstat |
|
| Placebo | Placebo Comparator | The patient will receive a daily dose of Placebo |
|
| Laroprovstat/Rosuvastatin dose combination 1 | Experimental | The patient will receive a daily dose of Laroprovstat/Rosuvastatin 1 |
|
| Laroprovstat/Rosuvastatin dose combination 2 | Experimental | The patient will receive a daily dose of Laroprovstat/Rosuvastatin 2 |
|
| Rosuvastatin dose 1 | Active Comparator |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Laroprovstat | Drug | daily oral dose of the Laroprovstat |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Relative change in LDL-C at 8 weeks | To compare the effect of treatment with FDC laroprovstat/rosuvastatin 2 versus the following on LDL-C at 8 weeks:
| 8 weeks |
| Relative change in LDL-C at 8 weeks | To compare the effect of treatment with FDC laroprovstat/rosuvastatin 1 versus the following on LDL-C at 8 weeks:
| 8 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Relative change in LDL-C | To compare the effect of treatment with FDC laroprovstat/rosuvastatin 1 versus rosuvastatin 2 alone on LDL-C at 8 weeks | 8 weeks |
| Relative change in Apo B | To compare the effect of treatment with FDC laroprovstat/rosuvastatin versus the individual components and placebo on apolipoprotein B (Apo B) at 8 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| AstraZeneca Clinical Study Information Center | Contact | +18772409479 | information.center@astrazeneca.com |
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Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal Vivli.org. All requests will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.
AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA PhRMA Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
When a request has been approved AstraZeneca will provide access to the anonymized individual patient-level data via secure research environment Vivli.org. Signed Data Usage Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information.
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The patient will receive a daily dose of Rosuvastatin 1
|
| Rosuvastatin dose 2 | Active Comparator | The patient will receive a daily dose of Rosuvastatin 2 |
|
| Rosuvastatin 1 |
| Drug |
daily oral dose of the Rosuvastatin 1 |
|
| Rosuvastatin 2 | Drug | daily oral dose of the Rosuvastatin 2 |
|
| Laroprovstat/Rosuvastatin 1 | Drug | daily oral dose of the Laroprovstat/Rosuvastatin 1 |
|
| Placebo to match rosuvastatin | Drug | daily oral dose of the Placebo to match Rosuvastatin |
|
| Placebo to match Laroprovstat and Laroprovstat/Rosuvastatin 1 | Drug | daily oral dose of the Placebo to match Laroprovstat and Laroprovstat/Rosuvastatin 1 |
|
| Laroprovstat/Rosuvastatin 2 | Drug | daily oral dose of the Laroprovstat/Rosuvastatin 2 |
|
| Placebo to match Laroprovstat/Rosuvastatin 2 | Drug | daily oral dose of the Placebo to match Laroprovstat/Rosuvastatin 2 |
|
| 8 weeks |
| Relative change in non-HDL-C | To compare the effect of treatment with FDC laroprovstat/rosuvastatin versus the individual components and placebo on non-high-density lipoprotein cholesterol (non-HDL-C) at 8 weeks | 8 weeks |
| Relative change in total cholesterol | To compare the effect of treatment with FDC laroprovstat/rosuvastatin versus the individual components and placebo on total cholesterol at 8 weeks | 8 weeks |
| ID | Term |
|---|---|
| D006937 | Hypercholesterolemia |
| ID | Term |
|---|---|
| D006949 | Hyperlipidemias |
| D050171 | Dyslipidemias |
| D052439 | Lipid Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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